Patients with neuromuscular diseases such as amyotrophic lateral sclerosis often suffer from central nervous system-mediated sleep disorders that can cause orthopnea, nocturnal hypoventilation, and a reduction in REM sleep. Noninvasive positive pressure ventilation (NIPPV) therapy in the form of with bi-level positive airway pressure (BiPAP) or continuous positive airway pressure CPAP) is commonly provided to these patients, with some success, in an effort to restore sleep toward normal. Further, NIPPV therapy has been shown to increase survival times of ALS patients. However, a significant percentage of patients do not tolerate the positive pressure intervention well, at least in part because of bulbar symptoms, such as difficulty with management of swallowing, saliva, aspiration, and communication, or other coping issues. Other therapeutic approaches to improving the quality of sleep in patients with neuromuscular diseases and associated central nervous system mediated disorders of sleep are desirable.
The therapeutic use of neuromodulation or neurostimulation in order to create a change in nerve conduction or muscle function at the site such modulation or stimulation has met with some success in various therapeutic circumstances. For example, periodic stimulation by spinal cord stimulators has been used to block pain sensation, periodic stimulation by deep brain stimulation (DBS) methodology has been used to block tremors, functional electrical stimulation (FES) has been able to create movement, periodic stimulation by vagus nerve stimulation (VNS) methodology has been able to block epileptic seizures, and intermittent stimulation by VNS has been shown to block hunger signals and create a sensation of satiety.
It would be desirable to have neuromodulatory or neurostimulatory therapeutic modalities available that would encourage a functionally beneficial outcome by introducing reflexive or automatic pathways that would work in conjunction with the applied therapy. This could be applied, for example, to conditions that compromise breathing particularly as it occurs during sleep, as in sleep apnea.